Trial Outcomes & Findings for Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors (NCT NCT02988817)
NCT ID: NCT02988817
Last Updated: 2023-08-01
Results Overview
The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, \>=G3 hemorrhage associated with \>=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, \>=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; \>= G3 diarrhoea and/or vomiting persisting \>48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any \>=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
306 participants
Primary outcome timeframe
From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimen
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment..
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment..
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing epidermal growth factor receptor (EGFR) mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors, received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or anaplastic lymphoma kinase (ALK) rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
3
|
10
|
11
|
3
|
3
|
3
|
6
|
3
|
22
|
16
|
25
|
25
|
44
|
25
|
55
|
21
|
26
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
3
|
10
|
11
|
3
|
3
|
3
|
6
|
3
|
22
|
16
|
25
|
25
|
44
|
25
|
55
|
21
|
26
|
Reasons for withdrawal
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment..
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment..
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing epidermal growth factor receptor (EGFR) mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors, received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or anaplastic lymphoma kinase (ALK) rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
3
|
1
|
2
|
1
|
1
|
1
|
1
|
12
|
6
|
6
|
4
|
5
|
4
|
11
|
4
|
2
|
|
Overall Study
Death
|
0
|
1
|
3
|
1
|
6
|
10
|
1
|
2
|
1
|
5
|
1
|
8
|
9
|
17
|
18
|
30
|
17
|
38
|
14
|
16
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
2
|
3
|
0
|
0
|
|
Overall Study
Sponsor decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
2
|
6
|
2
|
3
|
2
|
7
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or classical metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=55 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=21 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
>=18 to <65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
15 Participants
n=24 Participants
|
23 Participants
n=135 Participants
|
16 Participants
n=136 Participants
|
24 Participants
n=44 Participants
|
15 Participants
n=667 Participants
|
17 Participants
n=12 Participants
|
180 Participants
n=12 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
10 Participants
n=24 Participants
|
21 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
31 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
9 Participants
n=12 Participants
|
126 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
14 Participants
n=24 Participants
|
17 Participants
n=135 Participants
|
25 Participants
n=136 Participants
|
25 Participants
n=44 Participants
|
11 Participants
n=667 Participants
|
13 Participants
n=12 Participants
|
174 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
27 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
30 Participants
n=44 Participants
|
10 Participants
n=667 Participants
|
13 Participants
n=12 Participants
|
132 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
16 Participants
n=36 Participants
|
24 Participants
n=36 Participants
|
24 Participants
n=24 Participants
|
43 Participants
n=135 Participants
|
23 Participants
n=136 Participants
|
53 Participants
n=44 Participants
|
21 Participants
n=667 Participants
|
25 Participants
n=12 Participants
|
297 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
11 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
21 Participants
n=36 Participants
|
24 Participants
n=24 Participants
|
37 Participants
n=135 Participants
|
20 Participants
n=136 Participants
|
50 Participants
n=44 Participants
|
20 Participants
n=667 Participants
|
23 Participants
n=12 Participants
|
269 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
2 Participants
n=12 Participants
|
17 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimenPopulation: Dose-determining set included all participants from the Safety Set (participants who received at least 1 dose of enapotamab vedotin, had at least one valid post-baseline safety assessment, and were classified according to first dose received) who either met the minimum exposure criterion and completed the DLT observation period, or who experienced a DLT during Cycle 1.
The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, \>=G3 hemorrhage associated with \>=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, \>=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; \>= G3 diarrhoea and/or vomiting persisting \>48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any \>=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol).
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=2 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 through Day 1130 (maximum observed duration)Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening between the first dose of enapotamab vedotin and 30 days after the last dose received.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=56 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=20 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TEAE
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
11 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
22 Participants
|
16 Participants
|
25 Participants
|
25 Participants
|
44 Participants
|
25 Participants
|
56 Participants
|
20 Participants
|
26 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TESAE
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
5 Participants
|
16 Participants
|
10 Participants
|
16 Participants
|
12 Participants
|
33 Participants
|
7 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 1130 (maximum observed duration)Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=56 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=20 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin
TEAEs related to enapotamab vedotin
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
21 Participants
|
15 Participants
|
24 Participants
|
24 Participants
|
38 Participants
|
23 Participants
|
52 Participants
|
16 Participants
|
20 Participants
|
|
Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin
Treatment emergent infusion-related AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 1130 (maximum observed duration)Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=56 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=20 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
9 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
15 Participants
|
6 Participants
|
18 Participants
|
16 Participants
|
21 Participants
|
15 Participants
|
40 Participants
|
14 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 1130 (maximum observed duration)Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
Number of participants with laboratory measurements graded as Grade 3 or 4 by NCI-CTCAE v 4.03 is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=56 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=20 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Activated partial thromboplastin time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Alanine aminotransferase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Amylase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Aspartate aminotransferase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Calcium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Gamma-glutamyl transferase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Leukocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Lipase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Lymphocytes
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Magnesium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Neutrophils
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Potassium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Prothrombin Intl. Normalized Ratio
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Sodium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Triglycerides
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Alkaline Phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Hemoglobin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Albumin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or 4 Laboratory Results
Cholesterol
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3Population: Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
Cycle 1 Day 1
|
6.143 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
13.233 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
18.353 day*ug/mL
Geometric Coefficient of Variation 8.6
|
40.921 day*ug/mL
Geometric Coefficient of Variation 27.7
|
64.140 day*ug/mL
Geometric Coefficient of Variation 13.2
|
67.998 day*ug/mL
Geometric Coefficient of Variation 32.2
|
76.264 day*ug/mL
Geometric Coefficient of Variation 31.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
Cycle 3 Day 1
|
5.780 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
10.892 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
18.664 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
39.589 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
56.842 day*ug/mL
Geometric Coefficient of Variation 23.8
|
61.161 day*ug/mL
Geometric Coefficient of Variation 10.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
Cycle 1 Day 1
|
5.509 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
10.369 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
16.004 day*ug/mL
Geometric Coefficient of Variation 18.5
|
36.526 day*ug/mL
Geometric Coefficient of Variation 29.7
|
58.410 day*ug/mL
Geometric Coefficient of Variation 11.6
|
62.563 day*ug/mL
Geometric Coefficient of Variation 29.7
|
71.196 day*ug/mL
Geometric Coefficient of Variation 32.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
Cycle 3 Day 1
|
5.306 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
9.157 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
15.047 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
36.333 day*ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
51.541 day*ug/mL
Geometric Coefficient of Variation 21.4
|
57.759 day*ug/mL
Geometric Coefficient of Variation 11.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Cmax of conjugated enapotamab vedotin for dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 1
|
7.250 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
12.600 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
16.615 ug/mL
Geometric Coefficient of Variation 16.7
|
33.005 ug/mL
Geometric Coefficient of Variation 9.4
|
39.647 ug/mL
Geometric Coefficient of Variation 11.4
|
43.377 ug/mL
Geometric Coefficient of Variation 25.6
|
48.548 ug/mL
Geometric Coefficient of Variation 33.0
|
10.127 ug/mL
Geometric Coefficient of Variation 40.2
|
14.307 ug/mL
Geometric Coefficient of Variation 31.6
|
18.040 ug/mL
Geometric Coefficient of Variation 12.0
|
17.928 ug/mL
Geometric Coefficient of Variation 22.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.201 ug/mL
Geometric Coefficient of Variation 11.9
|
16.765 ug/mL
Geometric Coefficient of Variation 36.3
|
18.698 ug/mL
Geometric Coefficient of Variation 8.1
|
18.958 ug/mL
Geometric Coefficient of Variation 19.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.172 ug/mL
Geometric Coefficient of Variation 8.0
|
16.166 ug/mL
Geometric Coefficient of Variation 37.2
|
16.991 ug/mL
Geometric Coefficient of Variation 7.8
|
18.500 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 1
|
6.870 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
11.000 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
16.200 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
32.400 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
35.890 ug/mL
Geometric Coefficient of Variation 17.9
|
38.928 ug/mL
Geometric Coefficient of Variation 9.0
|
—
|
—
|
22.400 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
21.800 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
21.200 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24.100 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
22.800 ug/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The total CL of conjugated enapotamab vedotin in dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.679 L/day
Geometric Coefficient of Variation 9.4
|
3.084 L/day
Geometric Coefficient of Variation 93.8
|
3.402 L/day
Geometric Coefficient of Variation 31.3
|
2.629 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
Cycle 1 Day 1
|
4.053 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
3.446 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
3.538 L/day
Geometric Coefficient of Variation 21.8
|
2.307 L/day
Geometric Coefficient of Variation 28.3
|
2.202 L/day
Geometric Coefficient of Variation 22.2
|
2.205 L/day
Geometric Coefficient of Variation 25.4
|
1.783 L/day
Geometric Coefficient of Variation 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
Cycle 3 day 1
|
4.360 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
4.187 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
3.000 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
2.160 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
2.285 L/day
Geometric Coefficient of Variation 27.1
|
2.539 L/day
Geometric Coefficient of Variation 14.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.281 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
3.412 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Tmax of conjugated enapotamab vedotin for dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 1
|
0.06 Day
Interval 0.06 to 0.06
|
0.03 Day
Interval 0.03 to 0.03
|
0.036 Day
Interval 0.03 to 0.04
|
0.033 Day
Interval 0.03 to 0.04
|
0.032 Day
Interval 0.02 to 0.09
|
0.032 Day
Interval 0.02 to 0.04
|
0.03 Day
Interval 0.02 to 0.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.010 Day
Interval 13.96 to 14.88
|
14.058 Day
Interval 13.98 to 14.08
|
14.083 Day
Interval 14.0 to 14.19
|
13.98 Day
Interval 13.98 to 13.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 1
|
0.04 Day
Interval 0.04 to 0.04
|
0.03 Day
Interval 0.03 to 0.03
|
0.04 Day
Interval 0.04 to 0.04
|
0.030 Day
Interval 0.03 to 0.03
|
0.036 Day
Interval 0.02 to 0.05
|
0.042 Day
Interval 0.03 to 0.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.02 Day
Interval 14.02 to 14.02
|
13.98 Day
Interval 13.98 to 13.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The t1/2 of conjugated enapotamab vedotin for dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 1
|
0.87 Day
Interval 0.87 to 0.87
|
1.49 Day
Interval 1.49 to 1.49
|
1.362 Day
Interval 1.02 to 1.39
|
1.384 Day
Interval 1.19 to 1.65
|
2.004 Day
Interval 1.67 to 2.53
|
1.810 Day
Interval 1.53 to 2.74
|
2.153 Day
Interval 1.99 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.097 Day
Interval 0.66 to 1.56
|
1.398 Day
Interval 0.91 to 1.81
|
1.423 Day
Interval 0.77 to 1.96
|
2.05 Day
Interval 2.05 to 2.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 1
|
0.78 Day
Interval 0.78 to 0.78
|
1.07 Day
Interval 1.07 to 1.07
|
1.130 Day
Interval 1.13 to 1.13
|
1.68 Day
Interval 1.68 to 1.68
|
2.117 Day
Interval 1.55 to 2.9
|
2.035 Day
Interval 1.38 to 2.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.51 Day
Interval 1.51 to 1.51
|
1.44 Day
Interval 1.44 to 1.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Vss of conjugated enapotamab vedotin for dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 1
|
4.909 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
6.544 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
5.873 L/day
Geometric Coefficient of Variation 9.8
|
4.208 L/day
Geometric Coefficient of Variation 12.5
|
6.028 L/day
Geometric Coefficient of Variation 18.4
|
5.489 L/day
Geometric Coefficient of Variation 24.2
|
5.038 L/day
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
57.736 L/day
Geometric Coefficient of Variation 10.0
|
48.001 L/day
Geometric Coefficient of Variation 91.1
|
53.436 L/day
Geometric Coefficient of Variation 28.0
|
42.708 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 1
|
4.755 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
6.288 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
4.870 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
4.534 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
6.072 L/day
Geometric Coefficient of Variation 24.2
|
6.656 L/day
Geometric Coefficient of Variation 22.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
36.476 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
53.085 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC0-inf of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part
Cycle 1 Day 1
|
3832.48 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
6144.11 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
13673.7 day*pg/mL
Geometric Coefficient of Variation 110.4
|
26549.1 day*pg/mL
Geometric Coefficient of Variation 82.9
|
33494.5 day*pg/mL
Geometric Coefficient of Variation 47.1
|
50459.6 day*pg/mL
Geometric Coefficient of Variation 117.0
|
48626.4 day*pg/mL
Geometric Coefficient of Variation 95.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part
Cycle 3 Day 1
|
3248.46 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
7452.05 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
4338.20 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
47093.9 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
30512.0 day*pg/mL
Geometric Coefficient of Variation 47.8
|
34188.6 day*pg/mL
Geometric Coefficient of Variation 46.6
|
16754.5 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The AUC0-last of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC0-last of MMAE for 1Q3W Dose-escalation Part
Cycle 1 Day 1
|
3364.64 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
5980.86 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
13194.4 day*pg/mL
Geometric Coefficient of Variation 110.4
|
25549.3 day*pg/mL
Geometric Coefficient of Variation 80.8
|
31854.7 day*pg/mL
Geometric Coefficient of Variation 46.4
|
34659.4 day*pg/mL
Geometric Coefficient of Variation 81.2
|
38963.5 day*pg/mL
Geometric Coefficient of Variation 65.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC0-last of MMAE for 1Q3W Dose-escalation Part
Cycle3 Day 1
|
2642.23 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
7263.16 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
4156.66 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
44553.3 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
28890.0 day*pg/mL
Geometric Coefficient of Variation 47.4
|
31429.9 day*pg/mL
Geometric Coefficient of Variation 43.2
|
16354.3 day*pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Cmax of MMAE for dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of MMAE for Dose-escalation Part
Cycle 1 Day 1
|
700.000 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
947.000 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
1874.13 pg/mL
Geometric Coefficient of Variation 5
|
4036.47 pg/mL
Geometric Coefficient of Variation 81.8
|
4265.60 pg/mL
Geometric Coefficient of Variation 46.1
|
5154.58 pg/mL
Geometric Coefficient of Variation 61.9
|
5617.89 pg/mL
Geometric Coefficient of Variation 34.7
|
161.140 pg/mL
Geometric Coefficient of Variation 75.0
|
175.315 pg/mL
Geometric Coefficient of Variation 159.4
|
303.977 pg/mL
Geometric Coefficient of Variation 45.3
|
244.623 pg/mL
Geometric Coefficient of Variation 48.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of MMAE for Dose-escalation Part
Cycle 1 Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
738.227 pg/mL
Geometric Coefficient of Variation 28.2
|
766.467 pg/mL
Geometric Coefficient of Variation 91.4
|
1982.67 pg/mL
Geometric Coefficient of Variation 58.1
|
1553.93 pg/mL
Geometric Coefficient of Variation 86.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of MMAE for Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1715.54 pg/mL
Geometric Coefficient of Variation 42.8
|
2525.75 pg/mL
Geometric Coefficient of Variation 54.7
|
4379.50 pg/mL
Geometric Coefficient of Variation 58.2
|
3720.00 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of MMAE for Dose-escalation Part
Cycle 3 Day 1
|
631.000 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
1200.000 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
628.000 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
6500.00 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
3964.40 pg/mL
Geometric Coefficient of Variation 49.4
|
4127.31 pg/mL
Geometric Coefficient of Variation 39.3
|
2180.00 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
442.000 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
558.000 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of MMAE for Dose-escalation Part
Cycle 3 Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1060.00 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of MMAE for Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2960.00 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
5190.00 pg/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The total CL of MMAE in dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Total CL of MMAE in Dose-escalation Part
Cycle 1 Day 1
|
6497.09 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
7421.74 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
4748.64 L/day
Geometric Coefficient of Variation 87.2
|
3555.78 L/day
Geometric Coefficient of Variation 90.6
|
4216.71 L/day
Geometric Coefficient of Variation 42.0
|
2971.09 L/day
Geometric Coefficient of Variation 107.2
|
2813.05 L/day
Geometric Coefficient of Variation 35.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total CL of MMAE in Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4819.44 L/day
Geometric Coefficient of Variation 25.8
|
4666.23 L/day
Geometric Coefficient of Variation 35.5
|
2847.55 L/day
Geometric Coefficient of Variation 46.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total CL of MMAE in Dose-escalation Part
Cycle 3 day 1
|
7757.51 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
6119.12 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
12908.6 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
1815.52 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
4256.44 L/day
Geometric Coefficient of Variation 50.1
|
4542.22 L/day
Geometric Coefficient of Variation 42.8
|
5849.18 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Total CL of MMAE in Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3899.39 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
2507.90 L/day
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The Tmax of MMAE for dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of MMAE for Dose-escalation Part
Cycle 1 Day 1
|
2.95 Day
Interval 2.95 to 2.95
|
3.00 Day
Interval 3.0 to 3.0
|
2.938 Day
Interval 2.89 to 2.94
|
2.764 Day
Interval 2.72 to 2.83
|
2.852 Day
Interval 0.97 to 3.03
|
2.866 Day
Interval 1.0 to 6.85
|
2.942 Day
Interval 2.82 to 7.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of MMAE for Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15.950 Day
Interval 15.93 to 17.73
|
15.982 Day
Interval 15.97 to 15.99
|
15.911 Day
Interval 14.51 to 15.95
|
20.820 Day
Interval 20.82 to 20.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of MMAE for Dose-escalation Part
Cycle 3 Day 1
|
2.83 Day
Interval 2.83 to 2.83
|
2.87 Day
Interval 2.87 to 2.87
|
0.94 Day
Interval 0.94 to 0.94
|
2.83 Day
Interval 2.83 to 2.83
|
2.830 Day
Interval 0.94 to 3.96
|
2.727 Day
Interval 0.94 to 2.94
|
3.02 Day
Interval 3.02 to 3.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of MMAE for Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.93 Day
Interval 14.93 to 14.93
|
15.890 Day
Interval 15.89 to 15.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3Population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
The t1/2 of MMAE for dose-escalation part is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
t1/2 of MMAE for Dose-escalation Part
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.976 Day
Interval 2.78 to 6.06
|
3.115 Day
Interval 2.49 to 5.04
|
4.739 Day
Interval 2.85 to 8.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
t1/2 of MMAE for Dose-escalation Part
Cycle 1 Day 1
|
2.19 Day
Interval 2.19 to 2.19
|
2.35 Day
Interval 2.35 to 2.35
|
2.470 Day
Interval 2.1 to 2.7
|
2.620 Day
Interval 1.85 to 2.98
|
2.420 Day
Interval 2.02 to 3.75
|
3.128 Day
Interval 1.55 to 42.73
|
2.835 Day
Interval 2.45 to 3.22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
t1/2 of MMAE for Dose-escalation Part
Cycle 3 Day 1
|
1.94 Day
Interval 1.94 to 1.94
|
2.32 Day
Interval 2.32 to 2.32
|
2.71 Day
Interval 2.71 to 2.71
|
2.52 Day
Interval 2.52 to 2.52
|
2.746 Day
Interval 2.18 to 3.12
|
3.364 Day
Interval 2.85 to 4.99
|
1.98 Day
Interval 1.98 to 1.98
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
t1/2 of MMAE for Dose-escalation Part
Cycle 3 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.330 Day
Interval 2.33 to 2.33
|
3.37 Day
Interval 3.37 to 3.37
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 1130 (Dose-escalation part: Predose of Day 1 of Cycles 1 to 12, end of treatment [EOT], and 30 days after last study drug; Expansion part: Predose on Day 1 of Cycles 1 to 5, then every fourth cycle until PD)Population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
The ADA assessment was performed according to a tiered approach. First samples were screened for an ADA response; positively screened samples were analyzed in a confirmation method. Subsequently confirmed positive samples were analyzed for titre and the presence of neutralizing antibodies. Number of participants with ADA confirmed positive to enapotamab vedotin is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=56 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=20 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 44.5 months (maximum observed duration)Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
Radiological evaluation based on RECIST v1.1 was performed by the investigator using computed tomography (CT) scans/ magnetic resonance imaging (MRI) scans/ positron emission tomography (PET) scans. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=55 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=21 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Screening (within 2 weeks before starting of the study treatment) through Day 1130 (maximum observed duration)Population: Participants from the full analysis set with ovarian cancer who had an initial CA-125 level of at least twice the upper limit of the reference range within 2 weeks before starting the study treatment were evaluated for this outcome measure.
The best CA-125 response was evaluated in participants with ovarian cancer. A CA-125 partial response was defined as at least a 50% reduction in CA-125 levels in blood from a pretreatment sample. Participants who had a CA-125 partial response and had CA-125 level falls to within the reference range (0-35 units/mL) were classified as CA-125 complete responders. The response was confirmed and maintained for at least 28 days. The best overall response (CA-125 partial response and CA-125 complete response) is reported.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=2 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=2 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=19 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Best Cancer Antigen 125 (CA-125) Response
CA-125 partial response
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Best Cancer Antigen 125 (CA-125) Response
CA-125 complete response
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 44.5 months (maximum observed duration)Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
The DoR was defined as the number of months from the first documentation of objective tumor response (CR or PR) to the date of first progressive disease (PD) or death. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to \< 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD. The PD was defined as at least 20% increase in the sum of LD of target lesions taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new target and non-target lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=2 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=2 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part
|
—
|
4.2 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
4.1 Months
Interval 2.4 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
—
|
4.9 Months
Interval 2.6 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
3.0 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
NA Months
Interval 3.0 to
Median and upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
3.0 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
4.9 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 44.5 months (maximum observed duration)Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
The PFS was defined as the number of months from the date of first study drug administration to first PD or death. The PD was defined as at least 20% increase in the sum of longest diameters of target lesions taking as reference the smallest sum of the longest diameters recorded since the treatment started or the appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=55 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=21 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) as Assessed by Investigator
|
6.7 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
3.5 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
1.3 Months
Interval 1.2 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
5.3 Months
Interval 1.1 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
2.8 Months
Interval 1.4 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
2.6 Months
Interval 0.7 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
NA Months
Median and 95% confidence interval were not reached due to an insufficient events being observed.
|
1.6 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
1.6 Months
Interval 1.3 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
4.3 Months
Interval 1.0 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
0.8 Months
Interval 0.4 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
2.6 Months
Interval 1.2 to 2.8
|
2.6 Months
Interval 1.2 to 3.9
|
2.8 Months
Interval 1.3 to 5.0
|
2.6 Months
Interval 1.4 to 4.1
|
1.9 Months
Interval 1.6 to 2.1
|
1.6 Months
Interval 1.3 to 3.0
|
2.2 Months
Interval 1.4 to 3.9
|
2.6 Months
Interval 1.1 to 4.0
|
2.0 Months
Interval 1.4 to 4.1
|
SECONDARY outcome
Timeframe: Day 1 through 44.5 months (maximum observed duration)Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
Overall survival was defined as the number of months from date of first study drug administration to death. The OS was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 Participants
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 Participants
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 Participants
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=55 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=21 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 Participants
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
NA Months
Median and 95% confidence interval were not reached due to an insufficient events being observed.
|
4.3 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
6.4 Months
Interval 6.3 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
NA Months
Interval 6.7 to
Median and upper limit of 95% confidence interval were not reached due to an insufficient events being observed.
|
14.5 Months
Interval 3.1 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
7.6 Months
Interval 2.2 to 12.1
|
44.5 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
6.7 Months
Interval 6.7 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
14.3 Months
95% confidence interval was not reached due to an insufficient events being observed.
|
7.7 Months
Interval 4.3 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
21.7 Months
Interval 0.4 to
Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
|
16.5 Months
Interval 4.1 to 25.9
|
8.6 Months
Interval 3.6 to 19.1
|
9.2 Months
Interval 4.0 to 14.9
|
17.1 Months
Interval 5.7 to 24.3
|
7.0 Months
Interval 5.2 to 11.6
|
8.4 Months
Interval 6.5 to 12.4
|
11.3 Months
Interval 8.0 to 15.5
|
8.7 Months
Interval 5.8 to 14.1
|
8.0 Months
Interval 4.1 to 12.9
|
SECONDARY outcome
Timeframe: Baseline (Study Days -21 to 1) and EOT visit (Day 1100)Population: The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received in the expansion part. Participants who had tumor H-scores in membrane or cytoplasm assessed at Baseline and at the end of treatment visit were evaluated for this outcome measure.
Change in AXL expression (total humor H-score in membrane or cytoplasm) from Baseline to EOT visit for the expansion part is reported. The H-score captures both the intensity and proportion of AXL positive tumor cells and was defined by the formula: H-score = (1 × % 1+ tumor cells) + (2 × % 2+ tumor cells) + (3 × % 3+ tumor cells); where '1+' indicates weak staining intensity, '2+' indicates medium staining intensity, and '3+' indicates strong staining intensity. The H-score values ranges from 0 to 300. Lower H-scores represent lower AXL expression in the tumor sample, while higher scores represent stronger AXL expression in the tumor samples.
Outcome measures
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=1 Participants
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part
|
-8.0 Score on a scale
Standard Deviation NA
Standard deviation was not derived as only one participant was evaluated.
|
-1.0 Score on a scale
Standard Deviation NA
Standard deviation was not derived as only one participant was evaluated.
|
—
|
-30.0 Score on a scale
Standard Deviation NA
Standard deviation was not derived as only one participant was evaluated.
|
—
|
35.0 Score on a scale
Standard Deviation NA
Standard deviation was not derived as only one participant was evaluated.
|
-14.0 Score on a scale
Standard Deviation NA
Standard deviation was not derived as only one participant was evaluated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
Serious events: 7 serious events
Other events: 10 other events
Deaths: 6 deaths
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Serious events: 6 serious events
Other events: 11 other events
Deaths: 10 deaths
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 5 deaths
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Serious events: 15 serious events
Other events: 22 other events
Deaths: 8 deaths
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Serious events: 5 serious events
Other events: 16 other events
Deaths: 9 deaths
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Serious events: 16 serious events
Other events: 24 other events
Deaths: 17 deaths
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Serious events: 10 serious events
Other events: 25 other events
Deaths: 18 deaths
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Serious events: 16 serious events
Other events: 44 other events
Deaths: 30 deaths
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Serious events: 12 serious events
Other events: 25 other events
Deaths: 17 deaths
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Serious events: 33 serious events
Other events: 56 other events
Deaths: 38 deaths
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Serious events: 7 serious events
Other events: 20 other events
Deaths: 14 deaths
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Serious events: 14 serious events
Other events: 23 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 participants at risk
Participants with advanced and/or metastatic NSCLC with classical sensitizing classical EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 participants at risk
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 participants at risk
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 participants at risk
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 participants at risk
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 participants at risk
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=56 participants at risk
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=20 participants at risk
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 participants at risk
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
40.0%
4/10 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
31.8%
7/22 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
25.0%
4/16 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.1%
4/56 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Chest Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Death
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Fatigue
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Oedema
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Biliary Obstruction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Cholangitis Infective
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Pneumocystis Jirovecii Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Lipase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis Carcinomatosa
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Peritoneum
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial Effusion Malignant
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Acute Motor-Sensory Axonal Neuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Loss Of Consciousness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Product Issues
Device Occlusion
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.1%
4/56 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Obstruction Extrinsic
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
Other adverse events
| Measure |
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
n=1 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
n=1 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
n=10 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=11 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=6 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
n=3 participants at risk
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=22 participants at risk
Participants with advanced and/or metastatic NSCLC with classical sensitizing classical EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=16 participants at risk
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 participants at risk
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 participants at risk
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=44 participants at risk
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=25 participants at risk
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
n=56 participants at risk
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
n=20 participants at risk
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
|
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
n=26 participants at risk
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Hernia Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Inflammation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Infusion Site Reaction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Localised Oedema
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Malaise
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Medical Device Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Nodule
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Oedema
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
4/20 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Physical Deconditioning
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
2/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
22.7%
5/22 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.8%
3/16 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.4%
5/44 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
7/56 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Soft Tissue Inflammation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Temperature Intolerance
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Tenderness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Photophobia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Vaccination Site Reaction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Xerosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
40.0%
4/10 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
3/6 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
2/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
6/44 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
19.6%
11/56 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.4%
4/26 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Anaemia Macrocytic
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
40.0%
4/10 • Number of events 29 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
2/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
28.0%
7/25 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
36.0%
9/25 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
7/56 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.1%
4/56 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Blepharitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Borderline Glaucoma
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Cataract
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Diplopia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Dry Eye
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Eye Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Photopsia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Trichomegaly
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
60.0%
6/10 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
36.4%
4/11 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
2/6 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
25.0%
4/16 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
32.0%
8/25 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
22.7%
10/44 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
36.0%
9/25 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
19.6%
11/56 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
26.9%
7/26 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.1%
4/56 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
80.0%
8/10 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
63.6%
7/11 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
4/6 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
31.8%
7/22 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
31.2%
5/16 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
48.0%
12/25 • Number of events 15 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
52.0%
13/25 • Number of events 16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
25.0%
11/44 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
28.0%
7/25 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
55.4%
31/56 • Number of events 39 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
45.0%
9/20 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
42.3%
11/26 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
5/10 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
63.6%
7/11 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
4/6 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
22.7%
5/22 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
8/16 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
40.0%
10/25 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
40.0%
10/25 • Number of events 21 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
29.5%
13/44 • Number of events 17 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
36.0%
9/25 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
35.7%
20/56 • Number of events 28 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
30.0%
6/20 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
42.3%
11/26 • Number of events 18 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.4%
5/44 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
19.2%
5/26 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Duodenogastric Reflux
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Gingival Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Hyperaesthesia Teeth
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
60.0%
6/10 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
63.6%
7/11 • Number of events 17 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
3/3 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
4/6 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
63.6%
14/22 • Number of events 18 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
62.5%
10/16 • Number of events 12 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
44.0%
11/25 • Number of events 12 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
60.0%
15/25 • Number of events 20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
29.5%
13/44 • Number of events 19 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
60.0%
15/25 • Number of events 22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
39.3%
22/56 • Number of events 30 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
30.0%
6/20 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
42.3%
11/26 • Number of events 16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Neutropenic Colitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Salivary Duct Inflammation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
60.0%
6/10 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
63.6%
7/11 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
3/3 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
6/22 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.8%
3/16 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
24.0%
6/25 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.5%
9/44 • Number of events 15 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
28.0%
7/25 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
26.8%
15/56 • Number of events 21 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
4/20 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
26.9%
7/26 • Number of events 16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Application Site Reaction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Asthenia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Axillary Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Chest Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Chest Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Chills
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
4/44 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
19.2%
5/26 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Condition Aggravated
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Face Oedema
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
3/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
5/10 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
72.7%
8/11 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
3/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
83.3%
5/6 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
68.2%
15/22 • Number of events 15 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
8/16 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
64.0%
16/25 • Number of events 22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
56.0%
14/25 • Number of events 22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
52.3%
23/44 • Number of events 31 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
52.0%
13/25 • Number of events 17 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
55.4%
31/56 • Number of events 37 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
55.0%
11/20 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
13/26 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Feeling Abnormal
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
General disorders
Gait Disturbance
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Immune system disorders
Bronchiolitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Candida Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Citrobacter Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Cystitis Escherichia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Fungal Oesophagitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Lung Abscess
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.9%
5/56 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Paronychia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Pyuria
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Urinary Tract Candidiasis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
2/6 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.7%
6/56 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Vaginal Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Lip Injury
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Post Procedural Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Post Procedural Swelling
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Radiation Necrosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
36.4%
4/11 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
6/22 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.8%
3/16 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
24.0%
6/25 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
17.9%
10/56 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Amylase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
30.0%
3/10 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
6/22 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
2/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
24.0%
6/25 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
24.0%
6/25 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
23.2%
13/56 • Number of events 17 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Albumin Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
30.0%
6/20 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Iron Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Magnesium Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Phosphorus Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Sodium Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Brain Natriuretic Peptide Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Breath Sounds Abnormal
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
C-reactive Protein Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Gamma-glutamyltransferase Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
24.0%
6/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Lipase Increased
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
SARS-CoV-2 Test Positive
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Staphylococcus Test Positive
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Troponin T Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Troponin Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Vitamin B12 Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Weight Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
36.4%
4/11 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
2/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
22.7%
5/22 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
8/44 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
23.2%
13/56 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
19.2%
5/26 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Weight Increased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
30.0%
3/10 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
72.7%
8/11 • Number of events 12 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
3/6 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
36.4%
8/22 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
8/16 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
32.0%
8/25 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
31.8%
14/44 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
28.0%
7/25 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
46.4%
26/56 • Number of events 31 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
35.0%
7/20 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
46.2%
12/26 • Number of events 16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.1%
4/56 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Hypermagnesaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
2/16 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Hyperuricaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Investigations
Hypocalcaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
3/3 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
31.8%
7/22 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
2/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
21.4%
12/56 • Number of events 17 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
17.9%
10/56 • Number of events 20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.7%
6/56 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.4%
4/26 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.1%
4/56 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
2/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
28.0%
7/25 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
6/44 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
14.3%
8/56 • Number of events 13 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
19.2%
5/26 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
6/44 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.1%
9/56 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Limb Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Metabolism and nutrition disorders
Muscle Tightness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
2/6 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
25.0%
4/16 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
4/44 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.1%
4/56 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
25.0%
5/20 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
31.2%
5/16 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Amputation Stump Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Autonomic Nervous System Imbalance
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Autonomic Neuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.8%
3/16 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.9%
5/56 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.4%
4/26 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
6/44 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
19.2%
5/26 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.4%
5/44 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.9%
5/56 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
4/20 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.4%
4/26 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.4%
5/44 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Paresis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.1%
4/56 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
50.0%
5/10 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
2/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
40.9%
9/22 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
2/16 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
28.0%
7/25 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
25.0%
11/44 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
24.0%
6/25 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
19.6%
11/56 • Number of events 11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
26.9%
7/26 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Pyramidal Tract Syndrome
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Taste Disorder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
2/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Hallucination, Olfactory
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Hallucination, Visual
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
2/11 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.4%
5/44 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
5/25 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
14.3%
8/56 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
26.9%
7/26 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Bladder Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Calculus Bladder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Urge Incontinence
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Perineal Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Vulvovaginal Dryness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Vulvovaginal Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Reproductive system and breast disorders
Adductor Vocal Cord Weakness
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.4%
5/44 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.9%
5/56 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia Pharynx
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
66.7%
2/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
4/44 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.7%
6/56 • Number of events 8 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
30.0%
6/20 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
38.5%
10/26 • Number of events 12 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
1/1 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Discomfort
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway Cough Syndrome
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor Rhinitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
20.0%
2/10 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
27.3%
3/11 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
100.0%
3/3 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
2/6 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.2%
4/22 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
31.2%
5/16 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
28.0%
7/25 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
32.0%
8/25 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.8%
3/44 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
36.0%
9/25 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
25.0%
14/56 • Number of events 14 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
23.1%
6/26 • Number of events 6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Bullous
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Hair Texture Abnormal
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.6%
2/56 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Lichenoid Keratosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Nail Discolouration
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Nail Dystrophy
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
2/20 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
2/22 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
18.8%
3/16 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
6/44 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.7%
6/56 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.4%
5/44 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.7%
6/56 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
15.0%
3/20 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
11.5%
3/26 • Number of events 5 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
2/44 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
10.0%
1/10 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
33.3%
1/3 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.7%
1/6 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
13.6%
3/22 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
25.0%
4/16 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 9 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
16.0%
4/25 • Number of events 4 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.4%
3/56 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
8.0%
2/25 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.0%
3/25 • Number of events 3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
12.5%
7/56 • Number of events 7 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
3.8%
1/26 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
6.2%
1/16 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
2.3%
1/44 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
1.8%
1/56 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
7.7%
2/26 • Number of events 2 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.0%
1/25 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
4.5%
1/22 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
9.1%
1/11 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/20 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
|
Vascular disorders
Vascular Compression
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/10 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/11 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/6 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/3 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/22 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/16 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/44 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/25 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/56 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
5.0%
1/20 • Number of events 1 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
0.00%
0/26 • For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 12 months but less than 18 months from the end of study (database lock). The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER