Trial Outcomes & Findings for Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients (NCT NCT03737643)
NCT ID: NCT03737643
Last Updated: 2026-07-07
Results Overview
To determine the efficacy of durvalumab in combination with platinum based chemotherapy and bevacizumab and continued as maintenance in combination with bevacizumab and olaparib versus SoC platinum based chemotherapy in combination with bevacizumab by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Per MTP, the comparison of SoC+D+O v SoC in the Non-tbRCAm patients is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
ACTIVE_NOT_RECRUITING
PHASE3
1407 participants
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
2026-07-07
Participant Flow
Overall, 1407 patients were randomised into the study. Global Cohort: 1502 patients screened across 179 sites in 20 countries. 1130 were randomised in the Non-tBRCAm cohort and 154 allocated to the tBRCAm cohort. China Cohort: 134 patients screened across 29 sites; 124 were randomized. 1 patient in the China cohort was randomised prior to Global recruitment closure and hence included in both the Global and China cohort summaries. No patients in the tBRCAm cohort were enrolled from China
This study planned to allocate/randomise approximately 1254 patients with newly-diagnosed advanced ovarian cancer patients. In addition, a China cohort of approximately 120 non-tBRCAm patients with newly-diagnosed advanced ovarian cancer patients was planned to be randomised.
Participant milestones
| Measure |
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
Global tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
378
|
374
|
378
|
154
|
40
|
43
|
41
|
|
Overall Study
COMPLETED
|
153
|
160
|
172
|
100
|
26
|
31
|
34
|
|
Overall Study
NOT COMPLETED
|
225
|
214
|
206
|
54
|
14
|
12
|
7
|
Reasons for withdrawal
| Measure |
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
Global tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
201
|
196
|
186
|
46
|
14
|
11
|
7
|
|
Overall Study
Withdrawal by Subject
|
22
|
17
|
20
|
7
|
0
|
1
|
0
|
|
Overall Study
Pre-mature site closure and screen failure,
|
2
|
1
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
Baseline characteristics by cohort
| Measure |
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC + Durvalumab
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
Global tBRCAm: SoC + Durvalumab + Olaparib
n=154 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=40 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC + Durvalumab
n=43 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC + Durvalumab + Olaparib
n=41 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
Total
n=1408 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
79 Participants
n=6 Participants
|
|
Age, Continuous
|
58.7 Years
STANDARD_DEVIATION 9.9 • n=20 Participants
|
58.5 Years
STANDARD_DEVIATION 10.8 • n=20 Participants
|
60.2 Years
STANDARD_DEVIATION 10.4 • n=40 Participants
|
55.7 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
58.8 Years
STANDARD_DEVIATION 8.6 • n=9 Participants
|
52.8 Years
STANDARD_DEVIATION 8.7 • n=6 Participants
|
53.9 Years
STANDARD_DEVIATION 9.4 • n=6 Participants
|
58.4 Years
STANDARD_DEVIATION 10.4 • n=6 Participants
|
|
Age, Customized
>=65
|
110 Participants
n=20 Participants
|
126 Participants
n=20 Participants
|
135 Participants
n=40 Participants
|
37 Participants
n=5 Participants
|
10 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
427 Participants
n=6 Participants
|
|
Age, Customized
<65
|
268 Participants
n=20 Participants
|
248 Participants
n=20 Participants
|
243 Participants
n=40 Participants
|
117 Participants
n=5 Participants
|
30 Participants
n=9 Participants
|
39 Participants
n=6 Participants
|
36 Participants
n=6 Participants
|
981 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Female
|
378 Participants
n=20 Participants
|
374 Participants
n=20 Participants
|
378 Participants
n=40 Participants
|
154 Participants
n=5 Participants
|
40 Participants
n=9 Participants
|
43 Participants
n=6 Participants
|
41 Participants
n=6 Participants
|
1408 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
345 Participants
n=20 Participants
|
347 Participants
n=20 Participants
|
346 Participants
n=40 Participants
|
149 Participants
n=5 Participants
|
40 Participants
n=9 Participants
|
43 Participants
n=6 Participants
|
41 Participants
n=6 Participants
|
1311 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
55 Participants
n=20 Participants
|
52 Participants
n=20 Participants
|
47 Participants
n=40 Participants
|
45 Participants
n=5 Participants
|
40 Participants
n=9 Participants
|
43 Participants
n=6 Participants
|
41 Participants
n=6 Participants
|
323 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
MISSING
|
1 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
23 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
59 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
292 Participants
n=20 Participants
|
293 Participants
n=20 Participants
|
306 Participants
n=40 Participants
|
106 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
997 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 monthsPopulation: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To determine the efficacy of durvalumab in combination with platinum based chemotherapy and bevacizumab and continued as maintenance in combination with bevacizumab and olaparib versus SoC platinum based chemotherapy in combination with bevacizumab by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Per MTP, the comparison of SoC+D+O v SoC in the Non-tbRCAm patients is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=40 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=41 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
|
24.2 Months
Interval 22.7 to 26.8
|
17.4 Months
Interval 11.7 to 26.4
|
26.8 Months
Interval 23.5 to
Insufficient number of events to estimate upper limit.
|
19.3 Months
Interval 17.9 to 20.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until DCO1 - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 monthsPopulation: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Per MTP, the comparison of SoC+D+O v SoC in the Non-tBRCAm HRD positve population is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as as this was prespecified to be assessed only in the Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=140 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=20 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=28 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=143 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - (Full Analysis Set, HRD Positive)
|
37.3 Months
Interval 29.8 to
Insufficient number of events to estimate upper limit.
|
15.6 Months
Interval 9.3 to 23.9
|
26.8 Months
Interval 23.5 to
Insufficient number of events to estimate upper limit.
|
23 Months
Interval 21.2 to 24.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. For global cohort, assessed until DCO2 (18SEP2023) - up to 55 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To determine the efficacy of durvalumab assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Per MTP, the comparison of SoC+D v SoC is a secondary endpoint. SoC+D+O v SoC is reported separately as a primary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=40 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=43 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
|
20.6 Months
Interval 18.7 to 22.5
|
17.4 Months
Interval 11.7 to 26.4
|
21.7 Months
Interval 12.4 to
Insufficient number of events to estimate upper limit.
|
19.3 Months
Interval 17.9 to 20.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To determine the efficacy of durvalumab and olaparib assessed by OS in the first line treatment patients with newly diagnosed advanced ovarian cancer. Overall survival (OS) is defined as the time from randomisation/allocation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=40 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=43 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=41 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival - Full Analysis Set
|
48.5 Months
Interval 43.6 to 59.0
|
50.5 Months
Interval 45.2 to 65.1
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
49.6 Months
Interval 45.8 to 57.8
|
43.2 Months
Interval 34.1 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To determine the efficacy of durvalumab and olaparib assessed by OS in the first line treatment patients with newly diagnosed advanced ovarian cancer. Overall survival (OS) is defined as the time from randomisation/allocation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=148 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=140 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=20 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=143 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=30 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=28 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival - (Full Analysis Set, HRD-positive)
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
66.8 Months
Interval 60.9 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of PFS2 in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Time to second progression or death (PFS2) is defined as the time from the date of randomisation/allocation to the earliest of the progression event subsequent to first subsequent therapy or death. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=40 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=43 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=41 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Time to Second Progression or Death Based on Local Standard Clinical Practice (PFS2) - Full Analysis Set
|
34.6 Months
Interval 30.2 to 37.7
|
36.9 Months
Interval 32.7 to 41.1
|
27.5 Months
Interval 19.8 to
Insufficient number of events to estimate upper limit.
|
32.6 Months
Interval 30.7 to 35.4
|
28.8 Months
Interval 22.6 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of PFS2 in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Time to second progression or death (PFS2) is defined as the time from the date of randomisation/allocation to the earliest of the progression event subsequent to first subsequent therapy or death. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=148 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=140 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=20 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=143 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=30 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=28 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Time to Second Progression or Death Based on Local Standard Clinical Practice (PFS2) - (Full Analysis Set, HRD-positive)
|
51.3 Months
Interval 40.8 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
42.4 Months
Interval 38.8 to 58.9
|
34.1 Months
Interval 22.2 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022) and China (DCO1 17MAR2025)Population: All participants with measurable disease at baseline were included in the analysis. Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of ORR (Complete Response + Partial Response) by investigator assessment by modified RECIST 1.1: 1. in all patients with evaluable disease at baseline 2. prior to surgery in those patients planned to have IDS with evaluable disease at baseline. Objective response rate (ORR) is defined similarly for the non-tBRCAm and tBRCAm cohorts as the number (percentage) of patients with at least one investigator-assessed visit response of CR or PR and will be based on a subset of all randomised/allocated patients who have evaluable disease at baseline per the site investigator.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=288 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=296 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=117 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=296 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=26 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=30 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
n=27 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate Based on Investigator Assessment (Full Analysis Set)
|
68.1 Percentage of participants
|
74.3 Percentage of participants
|
72.6 Percentage of participants
|
70.3 Percentage of participants
|
57.7 Percentage of participants
|
56.7 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for China (DCO1 17MAR2025)Population: All participants with measurable disease at baseline were included in the analysis. Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of ORR (Complete Response + Partial Response) by investigator assessment by modified RECIST 1.1 1. in all patients with evaluable disease at baseline 2. prior to surgery in those patients planned to have IDS with evaluable disease at baseline. Objective response rate (ORR) is defined similarly for the non-tBRCAm and tBRCAm cohorts as the number (percentage) of patients with at least one investigator-assessed visit response of CR or PR and will be based on a subset of all randomised/allocated patients who have evaluable disease at baseline per the site investigator. This was prespecified to be assessed only in the non-tBRCAm cohort.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=107 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=103 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=16 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=108 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=21 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=18 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate Based on Investigator Assessment (Full Analysis Set, HRD-positive)
|
73.8 Percentage of participants
|
85.4 Percentage of participants
|
56.3 Percentage of participants
|
82.4 Percentage of participants
|
71.4 Percentage of participants
|
66.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022)Population: All participants with confirmed response were included in the analysis. Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of duration of response (DoR) in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Duration of response (DoR) is defined similarly for the non-tBRCAm and tBRCAm cohorts using the corresponding FAS among patients with a response (CR or PR), as the time from the date of first documented response (i.e., the first time at which the visit response is PR or CR) according to modified RECIST v1.1 as assessed by the investigator until date of documented progression or death in the absence of disease progression. This was prespecified to be assessed only in the Global patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=196 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=220 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=154 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=208 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Duration of Objective Response Based on Investigator Assessments (Full Analysis Set)
|
15.9 Months
Interval 8.4 to 28.3
|
22.3 Months
Interval 12.1 to
Insufficient DoR events to estimate upper confidence limit.
|
NA Months
Interval 24.9 to
Median and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
16.4 Months
Interval 8.3 to 23.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023).Population: All participants with confirmed response were included in the analysis. Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of duration of response (DoR) in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Duration of response (DoR) is defined similarly for the non-tBRCAm and tBRCAm cohorts using the corresponding FAS among patients with a response (CR or PR), as the time from the date of first documented response (i.e., the first time at which the visit response is PR or CR) according to modified RECIST v1.1 as assessed by the investigator until date of documented progression or death in the absence of disease progression. This was prespecified to be assessed only in Global Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=79 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=88 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=89 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Duration of Objective Response Based on Investigator Assessments (Full Analysis Set, HRD-positive)
|
19.3 Months
Interval 11.5 to 34.5
|
31.3 Months
Interval 18.4 to
Insufficient DoR events to estimate upper confidence limit.
|
—
|
19.4 Months
Interval 12.5 to 47.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of TFST in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Time to start of first subsequent therapy or death (TFST) is defined as the time from randomisation/allocation to the earlier of first subsequent therapy start date following study treatment discontinuation, or death. This was prespecified to be assessed only in Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=40 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=43 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=41 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Time to First Subsequent Therapy (TFST) - Full Analysis Set
|
21.9 Months
Interval 19.8 to 23.4
|
26.3 Months
Interval 24.2 to 29.5
|
19.0 Months
Interval 12.4 to 27.6
|
21.6 Months
Interval 20.1 to 23.4
|
21.7 Months
Interval 15.6 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of TFST in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Time to start of first subsequent therapy or death (TFST) is defined as the time from randomisation/allocation to the earlier of first subsequent therapy start date following study treatment discontinuation, or death. This was prespecified to be assessed only in Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=148 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=140 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=20 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=143 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=30 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=28 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Time to First Subsequent Therapy (TFST) - (Full Analysis Set, HRD-positive)
|
29.0 Months
Interval 25.1 to 39.2
|
41.4 Months
Interval 33.2 to 59.2
|
17.9 Months
Interval 11.7 to
Insufficient number of events to estimate upper limit.
|
25.8 Months
Interval 23.5 to 30.9
|
34.1 Months
Interval 16.8 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of TSST in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Time to second subsequent therapy or death (TSST) is defined as the time from randomisation/allocation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death. This was prespecified to be assessed only in Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=40 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=43 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=41 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Time to Second Subsequent Therapy (TSST) - Full Analysis Set
|
34.9 Months
Interval 31.8 to 37.8
|
38.5 Months
Interval 34.6 to 42.1
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
33.1 Months
Interval 31.6 to 36.6
|
30.6 Months
Interval 22.2 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of TSST in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Time to second subsequent therapy or death (TSST) is defined as the time from randomisation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death. This was prespecified to be assessed only in Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=148 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=140 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=20 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=143 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=30 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=28 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Time to Second Subsequent Therapy (TSST) - (Full Analysis Set, HRD-positive)
|
48.4 Months
Interval 41.8 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
46.8 Months
Interval 39.5 to 60.0
|
34.1 Months
Interval 22.2 to
Insufficient number of events to estimate upper limit.
|
NA Months
Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of TDT in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Time to permanent study treatment discontinuation or death (TDT) is defined as the time from randomisation/allocation to the earlier of the date of permanent study treatment discontinuation or death. This was prespecified to be assessed only in Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=40 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=43 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=41 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Time to Treatment Discontinuation (TDT) - Full Analysis Set
|
17.5 Months
Interval 15.2 to 19.4
|
20.4 Months
Interval 18.5 to 21.7
|
14.8 Months
Interval 10.4 to 23.0
|
18.4 Months
Interval 17.1 to 19.7
|
14.5 Months
Interval 9.0 to 22.4
|
22.0 Months
Interval 15.4 to 26.1
|
—
|
SECONDARY outcome
Timeframe: Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021). China FAS includes all patients who were randomised at sites in China.
To assess the efficacy of durvalumab and olaparib in terms of TDT in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Time to permanent study treatment discontinuation or death (TDT) is defined as the time from randomisation/allocation to the earlier of the date of permanent study treatment discontinuation or death. This was prespecified to be assessed only in Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=148 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=140 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=20 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=143 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
n=30 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
n=28 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Time to Treatment Discontinuation (TDT) - (Full Analysis Set, HRD-positive)
|
22.3 Months
Interval 19.4 to 24.3
|
24.7 Months
Interval 21.9 to 27.5
|
15.7 Months
Interval 9.2 to 24.0
|
22.0 Months
Interval 20.5 to 24.9
|
20.0 Months
Interval 11.8 to
Insufficient number of events to estimate upper limit.
|
21.8 Months
Interval 14.6 to 26.1
|
—
|
SECONDARY outcome
Timeframe: Assessed at week 96.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021).
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function. This was prespecified to be assessed only in Global Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Physical Function Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - Full Analysis Set
|
3.3 Score on a scale
Standard Error 1.25
|
3.0 Score on a scale
Standard Error 1.31
|
—
|
6.3 Score on a scale
Standard Error 1.30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at week 96.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021).
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function. This was prespecified to be assessed only in Global Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=148 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=140 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=143 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Physical Function Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - (Full Analysis Set, HRD Positive)
|
4.9 Score on a scale
Standard Error 1.88
|
7.6 Score on a scale
Standard Error 1.61
|
—
|
9.8 Score on a scale
Standard Error 1.53
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at week 96.Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021).
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function. This was prespecified to be assessed only in Global Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=374 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=378 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=378 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Global Health Status/QoL Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - Full Analysis Set
|
3.8 Score on a scale
Standard Error 1.33
|
4.6 Score on a scale
Standard Error 1.19
|
—
|
6.3 Score on a scale
Standard Error 1.23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at week 96Population: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 17 June 2021).
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function. This was prespecified to be assessed only in Global Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=148 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=140 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=143 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Global Health Status/QoL Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - (Full Analysis Set, HRD Positive)
|
6.3 Score on a scale
Standard Error 1.97
|
7.0 Score on a scale
Standard Error 1.64
|
—
|
8.5 Score on a scale
Standard Error 1.75
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at Day 85 pre-dose, Day 183 pre-dose and 3 months after last dose of durvalumab.Population: The PK analysis set comprises of all evaluable patients (a subset of those in the full analysis set) dosed with SoC + durvalumab or SoC + durvalumab + olaparib and providing at least one post-dose analysable concentration of durvalumab and/or olaparib.
To characterize the PK of durvalumab in combination with bevacizumab and olaparib. This was prespecified to be assessed only in Global Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=92 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=71 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Summary of Serum Concentrations (μg/mL) of Durvalumab for Each Treatment - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
Day 85, pre-dose
|
207988.974 μg/mL
Geometric Coefficient of Variation 30.1
|
—
|
—
|
218376.482 μg/mL
Geometric Coefficient of Variation 40.8
|
—
|
—
|
—
|
|
Summary of Serum Concentrations (μg/mL) of Durvalumab for Each Treatment - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
Day 148, pre-dose
|
252257.020 μg/mL
Geometric Coefficient of Variation 39.9
|
—
|
—
|
237360.027 μg/mL
Geometric Coefficient of Variation 36.8
|
—
|
—
|
—
|
|
Summary of Serum Concentrations (μg/mL) of Durvalumab for Each Treatment - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
Follow-up (3 months after last dose of durvalumab.)
|
25776.441 μg/mL
Geometric Coefficient of Variation 218.4
|
—
|
—
|
38355.597 μg/mL
Geometric Coefficient of Variation 112.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed on Day 148 post-dose (1-3 hours, 3-6 hours and 6-12 hours)Population: The PK analysis set comprises of all evaluable patients (a subset of those in the full analysis set) dosed with SoC + durvalumab + olaparib and providing at least one post-dose analysable concentration of olaparib.
To determine olaparib plasma concentrations via sparse sampling for population PK analyses. This was prespecified to be assessed only in Global Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=92 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Summary of Plasma Concentrations (μg/mL) of Olaparib - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
Day 148, 1-3 hours
|
—
|
—
|
—
|
5.8563 μg/mL
Geometric Coefficient of Variation 47.7
|
—
|
—
|
—
|
|
Summary of Plasma Concentrations (μg/mL) of Olaparib - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
Day 148, 3-6 hours
|
—
|
—
|
—
|
4.2425 μg/mL
Geometric Coefficient of Variation 38.4
|
—
|
—
|
—
|
|
Summary of Plasma Concentrations (μg/mL) of Olaparib - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
Day 148, 6-12 hours
|
—
|
—
|
—
|
2.5059 μg/mL
Geometric Coefficient of Variation 44.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed pre-infusion at Cycle 2, Cycle 4, Cycle 6 and the third cycle of the maintenance phase as well as 3 months after last dose of durvalumabPopulation: The ADA evaluable subjects are patients in the Safety Analysis Set who received at least 1 dose of durvalumab and have non-missing baseline ADA and at least 1 post-baseline ADA result.
To characterize the immunogenicity of durvalumab in combination with bevacizumab and olaparib. This was prespecified to be assessed only in Global Non-tBRCAm patients.
Outcome measures
| Measure |
Global Non-tBRCAm: SoC+D
n=74 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC+D+O
n=132 Participants
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC
n=58 Participants
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
ADA positive at any visit (ADA Prevalence)
|
2 Number of participants
|
6 Number of participants
|
—
|
4 Number of participants
|
—
|
—
|
—
|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
Transiently positive
|
0 Number of participants
|
1 Number of participants
|
—
|
1 Number of participants
|
—
|
—
|
—
|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
Treatment-emergent ADA-positive (ADA incidence)
|
0 Number of participants
|
1 Number of participants
|
—
|
1 Number of participants
|
—
|
—
|
—
|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
Treatment-boosted ADA
|
0 Number of participants
|
0 Number of participants
|
—
|
0 Number of participants
|
—
|
—
|
—
|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
Treatment-induced ADA (Positive Post-baseline only)
|
0 Number of participants
|
1 Number of participants
|
—
|
1 Number of participants
|
—
|
—
|
—
|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
ADA positive at baseline only
|
2 Number of participants
|
5 Number of participants
|
—
|
3 Number of participants
|
—
|
—
|
—
|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
ADA Positive Post-baseline and Positive at Baseline
|
0 Number of participants
|
0 Number of participants
|
—
|
0 Number of participants
|
—
|
—
|
—
|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
Persistently positive
|
0 Number of participants
|
0 Number of participants
|
—
|
0 Number of participants
|
—
|
—
|
—
|
|
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
Neutralising antibody positive at any visit
|
0 Number of participants
|
0 Number of participants
|
—
|
0 Number of participants
|
—
|
—
|
—
|
Adverse Events
Global Non-tBRCAm: SoC
Global Non-tBRCAm: SoC + Durvalumab
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
Global tBRCAm: SoC + Durvalumab + Olaparib
China Non-tBRCAm: SoC
China Non-tBRCAm: SoC + Durvalumab
China Non-tBRCAm: SoC + Durvalumab + Olaparib
Serious adverse events
| Measure |
Global Non-tBRCAm: SoC
n=376 participants at risk
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC + Durvalumab
n=373 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
n=378 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
Global tBRCAm: SoC + Durvalumab + Olaparib
n=153 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=40 participants at risk
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC + Durvalumab
n=43 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC + Durvalumab + Olaparib
n=41 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Enterocolitis infectious
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Hepatitis e
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Human anaplasmosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Infected lymphocele
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Infected seroma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Joint abscess
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
5/376 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.2%
12/378 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.2%
5/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Peritonitis
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.79%
3/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Peritonitis bacterial
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Pneumonia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/378 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.0%
3/153 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Post procedural infection
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Sepsis
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.6%
6/378 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.79%
3/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.80%
3/376 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/373 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.80%
3/376 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/378 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Superior mesenteric artery syndrome
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
5/376 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/378 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.0%
3/153 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Administration site extravasation
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Dehiscence
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Extravasation
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
General physical health deterioration
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Hernia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.79%
3/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Pain
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Performance status decreased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Pyrexia
|
1.3%
5/376 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.6%
10/378 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Paratracheal lymphadenopathy
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Biloma
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Biloma rupture
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Reticulocytosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Suspected drug-induced liver injury
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.79%
3/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.0%
3/153 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Abdominal infection
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Abdominal sepsis
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Abscess
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Anal abscess
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Appendicitis
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Covid-19
|
1.1%
4/376 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.9%
7/373 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/378 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Catheter site infection
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Device related infection
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Endocarditis
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Superinfection
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Suspected covid-19
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
8/376 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.6%
6/373 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/378 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Wound infection
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Diversion colitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative lymphocele
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Stoma site dermatitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Vaginal cuff dehiscence
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Norovirus test positive
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal perivascular epithelioid cell tumour
|
0.27%
1/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tubular breast carcinoma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Sciatica
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Secondary cerebellar degeneration
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Product Issues
Device dislocation
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Adjustment disorder
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Depression
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Panic reaction
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.6%
6/373 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Urinary bladder rupture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Reproductive system and breast disorders
Pelvic haemorrhage
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Addison's disease
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic rupture
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.79%
3/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/373 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.6%
6/378 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Aortic intramural haematoma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Embolism
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Hypertension
|
1.6%
6/376 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Lymphocele
|
1.1%
4/376 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Lymphorrhoea
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Immune-mediated endocrinopathy
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Eye disorders
Conjunctival disorder
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Eye disorders
Uveitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/373 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/378 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Erythroblastosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal wall cyst
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Ampullary polyp
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
9/376 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.7%
10/373 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.2%
12/378 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.9%
9/153 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
4/376 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/373 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/378 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Ileus
|
1.6%
6/376 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/373 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.79%
3/378 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.1%
4/376 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/373 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
Other adverse events
| Measure |
Global Non-tBRCAm: SoC
n=376 participants at risk
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
Global Non-tBRCAm: SoC + Durvalumab
n=373 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
n=378 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
Global tBRCAm: SoC + Durvalumab + Olaparib
n=153 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
China Non-tBRCAm: SoC
n=40 participants at risk
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
|
China Non-tBRCAm: SoC + Durvalumab
n=43 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
|
China Non-tBRCAm: SoC + Durvalumab + Olaparib
n=41 participants at risk
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
9.0%
34/376 • Number of events 73 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
8.0%
30/373 • Number of events 37 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.1%
42/378 • Number of events 99 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
13.1%
20/153 • Number of events 49 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.1%
4/376 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Nausea
|
30.6%
115/376 • Number of events 204 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
29.8%
111/373 • Number of events 192 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
57.9%
219/378 • Number of events 464 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
51.6%
79/153 • Number of events 141 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
37.5%
15/40 • Number of events 35 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
51.2%
22/43 • Number of events 59 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
61.0%
25/41 • Number of events 57 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
8.8%
33/376 • Number of events 43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.6%
47/373 • Number of events 65 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.5%
66/378 • Number of events 91 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
23/153 • Number of events 28 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Toothache
|
3.2%
12/376 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.6%
17/373 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.2%
12/378 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.9%
6/153 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.5%
7/40 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.7%
104/376 • Number of events 218 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
27.9%
104/373 • Number of events 177 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
33.9%
128/378 • Number of events 339 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
30.1%
46/153 • Number of events 128 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
60/376 • Number of events 101 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.6%
62/373 • Number of events 89 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.7%
97/378 • Number of events 170 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
26.8%
41/153 • Number of events 75 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.5%
9/40 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
30.2%
13/43 • Number of events 23 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
43.9%
18/41 • Number of events 60 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Asthenia
|
13.3%
50/376 • Number of events 75 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.3%
46/373 • Number of events 67 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.4%
62/378 • Number of events 88 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.1%
17/153 • Number of events 28 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.0%
10/40 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
23.3%
10/43 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
26.8%
11/41 • Number of events 23 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Chest discomfort
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Fatigue
|
27.9%
105/376 • Number of events 148 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
27.1%
101/373 • Number of events 153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
35.7%
135/378 • Number of events 224 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
30.7%
47/153 • Number of events 74 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Influenza like illness
|
1.9%
7/376 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/378 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.3%
5/153 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Malaise
|
1.9%
7/376 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/373 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.0%
15/378 • Number of events 26 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.3%
7/43 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.0%
9/41 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Mucosal inflammation
|
5.6%
21/376 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.8%
18/373 • Number of events 28 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.9%
26/378 • Number of events 35 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.9%
9/153 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Oedema peripheral
|
5.3%
20/376 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.0%
15/373 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.3%
24/378 • Number of events 30 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.3%
5/153 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
General disorders
Pyrexia
|
6.9%
26/376 • Number of events 43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
13.7%
51/373 • Number of events 77 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.9%
64/378 • Number of events 78 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.6%
27/153 • Number of events 35 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.9%
9/43 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
19.5%
8/41 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.9%
7/373 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.6%
4/153 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.2%
42/376 • Number of events 65 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.5%
39/373 • Number of events 54 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.9%
60/378 • Number of events 111 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
18.3%
28/153 • Number of events 51 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Covid-19
|
7.7%
29/376 • Number of events 29 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.1%
34/373 • Number of events 34 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.1%
61/378 • Number of events 72 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.8%
12/153 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
35.0%
14/40 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
32.6%
14/43 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
39.0%
16/41 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Coronavirus infection
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/378 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Cystitis
|
4.5%
17/376 • Number of events 27 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.2%
27/373 • Number of events 45 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.3%
24/378 • Number of events 39 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.8%
12/153 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Gingivitis
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/373 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/378 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.2%
8/153 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Herpes zoster
|
1.1%
4/376 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.9%
7/373 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/378 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.9%
9/153 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Influenza
|
1.1%
4/376 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/373 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/378 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
20/376 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.7%
25/373 • Number of events 28 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.3%
24/378 • Number of events 36 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.1%
17/153 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.2%
5/41 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
27.4%
103/376 • Number of events 156 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
31.9%
119/373 • Number of events 192 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
53.7%
203/378 • Number of events 390 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
54.9%
84/153 • Number of events 178 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
75.0%
30/40 • Number of events 85 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
74.4%
32/43 • Number of events 79 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
82.9%
34/41 • Number of events 156 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Pneumonia
|
1.1%
4/376 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.6%
6/378 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Suspected covid-19
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
8/376 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.7%
10/373 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.8%
18/378 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.9%
6/153 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.5%
9/40 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.1%
7/41 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Infections and infestations
Urinary tract infection
|
16.8%
63/376 • Number of events 93 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
56/373 • Number of events 94 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
18.0%
68/378 • Number of events 128 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
13.7%
21/153 • Number of events 34 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.5%
9/40 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.6%
11/43 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
31.7%
13/41 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
23/376 • Number of events 36 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
26/373 • Number of events 31 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
8.2%
31/378 • Number of events 38 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.2%
8/153 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
30.0%
12/40 • Number of events 32 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
37.2%
16/43 • Number of events 28 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
46.3%
19/41 • Number of events 56 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Amylase increased
|
4.5%
17/376 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.9%
22/373 • Number of events 25 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.2%
16/378 • Number of events 25 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.2%
8/153 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
3.5%
13/376 • Number of events 22 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
28/373 • Number of events 41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.1%
27/378 • Number of events 42 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.2%
8/153 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
47.5%
19/40 • Number of events 44 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
41.9%
18/43 • Number of events 40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
48.8%
20/41 • Number of events 69 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.2%
12/376 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.7%
10/373 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.3%
20/378 • Number of events 28 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.6%
4/153 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.2%
5/41 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood bilirubin increased
|
1.9%
7/376 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.53%
2/378 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.0%
3/153 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood creatinine increased
|
2.9%
11/376 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.3%
16/373 • Number of events 22 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
35/378 • Number of events 57 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.2%
11/153 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
19.5%
8/41 • Number of events 29 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.9%
7/376 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/373 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/378 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.6%
4/153 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 29 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.3%
7/43 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.7%
10/376 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/373 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.3%
20/378 • Number of events 22 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood urea increased
|
1.1%
4/376 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/378 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Blood uric acid increased
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Fibrin d dimer increased
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.5%
13/376 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/373 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.9%
11/378 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.0%
8/40 • Number of events 26 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
23.3%
10/43 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
26.8%
11/41 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Lipase increased
|
4.8%
18/376 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.4%
24/373 • Number of events 29 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/378 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
8.5%
13/153 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Lymphocyte count decreased
|
1.1%
4/376 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.9%
7/378 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.6%
4/153 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.5%
7/40 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Neutrophil count decreased
|
15.7%
59/376 • Number of events 103 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
56/373 • Number of events 112 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.7%
67/378 • Number of events 148 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.7%
24/153 • Number of events 47 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
67.5%
27/40 • Number of events 99 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
53.5%
23/43 • Number of events 89 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
68.3%
28/41 • Number of events 216 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Platelet count decreased
|
8.2%
31/376 • Number of events 56 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.2%
38/373 • Number of events 63 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
13.5%
51/378 • Number of events 98 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.4%
19/153 • Number of events 26 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
47.5%
19/40 • Number of events 65 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
48.8%
21/43 • Number of events 56 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
61.0%
25/41 • Number of events 101 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Protein urine present
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Urinary occult blood positive
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.0%
8/40 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.2%
5/41 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Weight decreased
|
4.3%
16/376 • Number of events 16 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.0%
15/373 • Number of events 16 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.0%
15/378 • Number of events 19 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.6%
7/153 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
23.3%
10/43 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.0%
9/41 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
Weight increased
|
2.1%
8/376 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/373 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/378 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.2%
8/153 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
40.0%
16/40 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
41.9%
18/43 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
19.5%
8/41 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
White blood cell count decreased
|
10.1%
38/376 • Number of events 74 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.5%
39/373 • Number of events 82 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
53/378 • Number of events 122 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.5%
16/153 • Number of events 34 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
60.0%
24/40 • Number of events 69 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
58.1%
25/43 • Number of events 94 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
65.9%
27/41 • Number of events 150 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
19.5%
8/41 • Number of events 27 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.4%
43/376 • Number of events 53 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
13.7%
51/373 • Number of events 66 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.2%
65/378 • Number of events 88 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.3%
25/153 • Number of events 33 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.0%
10/40 • Number of events 22 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.6%
11/43 • Number of events 37 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
34.1%
14/41 • Number of events 33 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.1%
4/378 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
14/376 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/373 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/378 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.9%
6/153 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.3%
5/376 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.80%
3/373 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.6%
6/378 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.3%
5/376 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.6%
6/378 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
18.6%
8/43 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.1%
8/376 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/373 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/378 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
27.5%
11/40 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
34.9%
15/43 • Number of events 28 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
26.8%
11/41 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.80%
3/376 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/378 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.6%
4/153 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
18/376 • Number of events 23 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.0%
15/373 • Number of events 16 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.0%
15/378 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.2%
11/153 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.5%
7/40 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.6%
11/43 • Number of events 16 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
19.5%
8/41 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.3%
16/376 • Number of events 26 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.6%
17/373 • Number of events 19 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.2%
12/378 • Number of events 22 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.5%
10/153 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.7%
14/376 • Number of events 19 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.6%
21/373 • Number of events 27 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/378 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.0%
3/153 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.8%
127/376 • Number of events 198 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
34.6%
129/373 • Number of events 191 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
37.6%
142/378 • Number of events 201 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
33.3%
51/153 • Number of events 79 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.0%
10/40 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
18.6%
8/43 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.0%
9/41 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
45/376 • Number of events 49 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.9%
37/373 • Number of events 41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.1%
38/378 • Number of events 45 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.4%
19/153 • Number of events 22 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
12/376 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.9%
11/373 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.3%
20/378 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.5%
10/153 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.2%
76/376 • Number of events 105 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
21.7%
81/373 • Number of events 114 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
18.3%
69/378 • Number of events 120 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.9%
32/153 • Number of events 52 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
23.3%
10/43 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
24.4%
10/41 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
26/376 • Number of events 35 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.1%
34/373 • Number of events 40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.4%
43/378 • Number of events 62 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
8.5%
13/153 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.1%
7/41 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.54%
2/373 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.26%
1/378 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.65%
1/153 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Dizziness
|
8.5%
32/376 • Number of events 41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
26/373 • Number of events 34 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.5%
36/378 • Number of events 51 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
8.5%
13/153 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Dysgeusia
|
5.6%
21/376 • Number of events 27 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.4%
24/373 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.4%
28/378 • Number of events 36 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.5%
16/153 • Number of events 26 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/373 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Headache
|
20.7%
78/376 • Number of events 113 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.1%
75/373 • Number of events 108 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.0%
83/378 • Number of events 122 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.0%
26/153 • Number of events 42 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.27%
1/376 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.6%
6/378 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.0%
3/153 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
30.0%
12/40 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
27.9%
12/43 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
48.8%
20/41 • Number of events 34 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
15.4%
58/376 • Number of events 64 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.4%
61/373 • Number of events 69 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
16.9%
64/378 • Number of events 77 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
13.1%
20/153 • Number of events 25 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Paraesthesia
|
8.0%
30/376 • Number of events 33 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.8%
29/373 • Number of events 32 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.4%
28/378 • Number of events 33 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.9%
9/153 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.2%
57/376 • Number of events 66 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.7%
55/373 • Number of events 61 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.7%
67/378 • Number of events 77 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
17.0%
26/153 • Number of events 26 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
9.0%
34/376 • Number of events 37 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.8%
29/373 • Number of events 32 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
8.7%
33/378 • Number of events 35 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.2%
11/153 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Psychiatric disorders
Insomnia
|
9.3%
35/376 • Number of events 40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
28/373 • Number of events 31 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.7%
29/378 • Number of events 37 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.1%
17/153 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Haematuria
|
2.9%
11/376 • Number of events 16 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
5/373 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.1%
8/378 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.0%
3/153 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
47/376 • Number of events 64 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.7%
40/373 • Number of events 51 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.1%
23/378 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
8.5%
13/153 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
40.0%
16/40 • Number of events 25 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
32.6%
14/43 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
41.5%
17/41 • Number of events 33 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
23/376 • Number of events 36 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.7%
36/373 • Number of events 43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.8%
41/378 • Number of events 49 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.2%
11/153 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.3%
4/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
20/376 • Number of events 22 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.4%
24/373 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
19/378 • Number of events 23 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.9%
6/153 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.7%
44/376 • Number of events 57 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
13.9%
52/373 • Number of events 63 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.9%
45/378 • Number of events 58 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.2%
11/153 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.9%
56/376 • Number of events 65 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.5%
43/373 • Number of events 54 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.4%
47/378 • Number of events 65 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.4%
19/153 • Number of events 36 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.0%
79/376 • Number of events 79 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
23.6%
88/373 • Number of events 91 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
26.2%
99/378 • Number of events 104 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
18.3%
28/153 • Number of events 30 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.0%
10/40 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.9%
9/43 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
11/376 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.5%
13/373 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.3%
20/378 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.3%
5/153 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.6%
36/376 • Number of events 45 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.5%
58/373 • Number of events 76 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.4%
47/378 • Number of events 58 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.4%
19/153 • Number of events 23 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.6%
11/43 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
29/376 • Number of events 36 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.6%
47/373 • Number of events 59 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.4%
47/378 • Number of events 62 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
15/153 • Number of events 21 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.0%
2/40 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.9%
9/43 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
19.5%
8/41 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Hot flush
|
4.3%
16/376 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.5%
13/373 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.3%
20/378 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.3%
5/153 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.3%
1/43 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Vascular disorders
Hypertension
|
33.0%
124/376 • Number of events 146 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
30.3%
113/373 • Number of events 143 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.9%
98/378 • Number of events 121 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.9%
32/153 • Number of events 47 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
32.5%
13/40 • Number of events 15 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
6/43 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.6%
6/41 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
2.1%
8/376 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.5%
43/373 • Number of events 49 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.6%
25/378 • Number of events 32 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
6.5%
10/153 • Number of events 11 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.3%
3/41 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
6.9%
26/376 • Number of events 28 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
21.2%
79/373 • Number of events 93 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
20.4%
77/378 • Number of events 89 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
23.5%
36/153 • Number of events 40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.5%
5/40 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
18.6%
8/43 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
39.0%
16/41 • Number of events 36 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.1%
8/376 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/373 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
9/378 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.0%
3/153 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.7%
10/376 • Number of events 10 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.0%
15/373 • Number of events 16 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.4%
13/378 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.9%
6/153 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.0%
3/43 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
12.2%
5/41 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.8%
67/376 • Number of events 84 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.0%
82/373 • Number of events 103 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.0%
83/378 • Number of events 116 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
23/153 • Number of events 31 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
15.0%
6/40 • Number of events 6 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
18.6%
8/43 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
26.8%
11/41 • Number of events 18 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.4%
39/376 • Number of events 51 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.9%
37/373 • Number of events 44 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
14.0%
53/378 • Number of events 70 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.8%
18/153 • Number of events 24 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 5 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
11.6%
5/43 • Number of events 8 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
9.8%
4/41 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Constipation
|
24.7%
93/376 • Number of events 133 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
24.9%
93/373 • Number of events 136 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
31.0%
117/378 • Number of events 193 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
23.5%
36/153 • Number of events 52 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
27.5%
11/40 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
25.6%
11/43 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
24.4%
10/41 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.0%
109/376 • Number of events 164 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
30.0%
112/373 • Number of events 177 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
29.1%
110/378 • Number of events 197 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
24.2%
37/153 • Number of events 64 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
22.5%
9/40 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
23.3%
10/43 • Number of events 13 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
26.8%
11/41 • Number of events 23 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.53%
2/376 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.4%
20/373 • Number of events 20 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.4%
13/378 • Number of events 14 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.3%
2/153 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/40 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
20/376 • Number of events 25 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.9%
22/373 • Number of events 25 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.9%
30/378 • Number of events 34 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
5.2%
8/153 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.5%
1/40 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/41 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/376 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.27%
1/373 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/378 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/153 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
7.5%
3/40 • Number of events 3 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
0.00%
0/43 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
2.4%
1/41 • Number of events 1 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.9%
11/376 • Number of events 12 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
1.9%
7/373 • Number of events 7 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
3.7%
14/378 • Number of events 17 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.6%
7/153 • Number of events 9 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
10.0%
4/40 • Number of events 4 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.7%
2/43 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
4.9%
2/41 • Number of events 2 • For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place